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UCB Media Room: ACR 2019 Data Highlights Release


[08/11/2019 | 07:00]

** UCB Presents New Data From Rheumatology Portfolio Addressing Unmet Needs=
in Axial Spondyloarthritis, Psoriatic Arthritis and Lupus at 2019 ACR/ARP

=C2=B7 Oral presentations include data on improvements in clinical and pati=
ent-reported outcomes with early CIMZIA (certolizumab pegol) treatment in n=
on-radiographic axial spondyloarthritis, and a reduction in anterior uveiti=
s flares in axial spondyloarthritis patients following one year of treatmen=
t with CIMZIA
=C2=B7 Oral presentations of new 48-week data from Phase 2b trials of inves=
tigational molecule bimekizumab support the potential value of dual neutral=
ization of IL-17A and IL-17F in psoriatic arthritis and ankylosing spondyli=
=C2=B7 Oral presentation of data from the Phase 2b trial of investigational=
molecule dapirolizumab pegol in patients with moderately to severely activ=
e systemic lupus erythematosus

Brussels, Belgium =E2=80=93 08=C2=A0November 2019 =E2=80=93 UCB, a global b=
iopharmaceutical company, today announced important new rheumatology data b=
eing presented on CIMZIA^=C2=AE (certolizumab pegol) and investigational mo=
lecules bimekizumab and dapirolizumab pegol at the 2019 American College of=
Rheumatology and the Association of Rheumatology Professionals (ACR/ARP) A=
nnual Meeting in Atlanta, on November 8-13.=C2=A0

=E2=80=9CUCB research presented at the 2019 ACR/ARP congress reflects our l=
eadership in addressing unmet patient needs and providing treatment options=
that could make a meaningful difference for people living with axSpA, PsA =
and lupus. The breadth and depth of UCB=E2=80=99s 13 data presentations are=
intended to improve our understanding of how best to address these serious=
diseases, which profoundly impact patients=E2=80=99 lives. UCB continues t=
o deliver on its Patient Value Strategy to connect the unmet needs of patie=
nts with innovative science,=E2=80=9D said Emmanuel Caeymaex, Head of Immun=
ology and Executive Vice President, Immunology Solutions, UCB.=C2=A0

A post-hoc analysis of the 52-week data from the Phase 3 C-AXSPAND study of=
CIMZIA will be shared in an oral presentation. The analysis showed that no=
n-radiographic axial spondyloarthrtis (nr-axSpA) patients with less than fi=
ve years of symptoms prior to initiation of CIMZIA treatment had greater im=
provements across signs and symptoms of disease and quality of life, compar=
ed to patients with at least five years of symptoms prior to CIMZIA treatme=
nt.^1=C2=A0These data suggest the value of diagnosing nr-axSpA patients and=
initiating anti-TNF treatment at an early stage of disease to help improve=
clinical outcomes. Nr-axSpA is a chronic inflammatory arthritis predominan=
tly affecting the spine and sacroiliac joints, and is a distinct condition =
within the spondyloarthritis family of chronic inflammatory diseases. In nr=
-axSpA, there is no definitive radiographic sacroiliitis, though more sensi=
tive magnetic resonance imaging (MRI) testing may detect evidence of active=
sacroiliitis, visible as inflammation in the sacroiliac joints.^2

Earlier this year, CIMZIA became the first and only treatment to gain FDA a=
pproval in the U.S. for the treatment of active nr-axSpA with objective sig=
ns of inflammation. The approval was based on the C-AXSPAND study, which de=
monstrated a statistically significant number of patients treated with CIMZ=
IA, in addition to non-biologic background medications (NBBM), reached a Ma=
jor Improvement in ASDAS (Ankylosing Spondylitis Disease Activity Score) ov=
er the 52-week trial, versus placebo plus NBBM.^3

Interim 48-week results from a Phase 4 multicenter open-label C-VIEW study =
will be shared in an oral presentation, showing a significant impact of CIM=
ZIA on reductions in the acute anterior uveitis flare rate in axial spondyl=
oarthritis (axSpA) patients. C-VIEW is the first study to include a broad p=
opulation of axSpA patients with active disease, HLA-B27 positivity and a d=
ocumented history of acute anterior uveitis, the most common extra-articula=
r manifestation in axSpA, affecting up to 40 percent of patients and causin=
g a significant burden.^4

Additional presentations focus on patient-reported outcomes for axSpA patie=
nts treated with CIMZIA. Positive C-AXSPAND study results show substantial =
improvements in sleep quality and other clinical outcomes that are importan=
t to patients, such as stiffness and fatigue.^5=C2=A0New research on the im=
pact of treatment with CIMZIA on improvements in work and household product=
ivity as well as social participation for patients with nr-axSpA will be pr=
esented.^6 Additional data from the RAPID-axSpA study showing that CIMZIA t=
reatment in axSpA patients was associated with rapid and sustained reductio=
n in active inflammation, no increase in sclerosis and erosions, and a negl=
igible increase in fatty lesions in the vertebral edges of the spine also w=
ill be presented.^7

The RAPID-PsA study on CIMZIA in psoriatic arthritis (PsA) evaluated the re=
lationship between PsA disease activity and structural progression over 216=
weeks of treatment with CIMZIA. The study showed that it is important for =
patients to achieve remission or low disease activity to prevent long-term =
structural damage, particularly in patients at risk of radiographic progres=

An oral presentation will share efficacy and safety data from the Phase 2b =
clinical trial of the investigational molecule, dapirolizumab pegol, in pat=
ients with moderately to severely active systemic lupus erythematosus (SLE)=
.^9 The primary objective of the study was to establish a dose-response rel=
ationship for dapirolizumab pegol using pre-specified models. The study dem=
onstrated consistent and potentially meaningful improvements for the majori=
ty of clinical endpoints in patients treated with dapirolizumab pegol compa=
red with placebo. Upon study drug withdrawal, immunologic parameters return=
ed to baseline levels, while pre-specified clinical outcomes stabilized. No=
ne of the pre-specified dose-response models could be selected; thus, the p=
rimary endpoint was not met. Dapirolizumab pegol was well tolerated and dem=
onstrated an acceptable safety profile. UCB and Biogen are collaborating on=
the development and commercialization of dapirolizumab pegol and have init=
iated preparations for a Phase 3 program in patients with active SLE despit=
e standard-of-care treatment.

In addition, the company will share 48-week results from the Phase 2b dose =
finding studies of its investigational pipeline molecule, bimekizumab, in P=
sA and ankylosing spondylitis (AS) in separate oral presentations. The stud=
ies showed that treatment with bimekizumab resulted in achievement of low a=
nd/or minimal disease activity in patients with PsA, which were maintained =
to week 48 as well as sustained improvement in patients with active AS.^10,=
11 The AS study showed that significantly more bimekizumab-treated patients=
achieved ASAS40 (Assessment of SpondyloArthritis International Society 40 =
percent response) at week 12, compared to placebo, and that these results w=
ere sustained to week 48 in the majority of patients. The safety profile wa=
s consistent with previous Phase 2 studies, with no new safety findings obs=

The safety and efficacy of bimekizumab and dapirolizumab pegol have not bee=
n established, and they are not approved by any regulatory authority worldw=

UCB also will be sponsoring a symposium featuring a panel of experts discus=
sing the challenges in recognizing, diagnosing and managing nr-axSpA. A ful=
l list of UCB-sponsored data can be found below.

Following is a guide to the UCB-sponsored data presentations:

UCB Sponsored Non-CME Symposia:=C2=A0

A New Horizon in Recognition and Management of Patients With nr-axSpA, A. D=
eodhar, W. Maksymowych, L. Gensler, M. Rudwaleit
=E2=80=A2=C2=A0 Date/time: November 11, 2019: 6:30PM-8:30PM ET
=E2=80=A2=C2=A0 Location: Marriott Hotel, Rooms A601 and A602

CIMZIA Oral Presentations:

Earlier Treatment of Non-Radiographic Axial Spondyloarthritis with Certoliz=
umab Pegol Results in Improved=C2=A0Clinical and Patient-Reported Outcomes,=
J. Kay, L. Gensler, A. Deodhar, W. Maksymowych, N. Haroon, S. Auteri, N. d=
e Peyrecave, T. Kumke, B. Hoepken, L. Bauer, M. Rudwaleit
=E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 4:30PM-6:00PM ET
=E2=80=A2=C2=A0=C2=A0Location: GWCC Building B, B405-B407

Reduction of Anterior Uveitis Flares in Patients with Axial Spondyloarthrit=
is Following 1 Year of Treatment with Certolizumab Pegol: 48-Week Interim R=
esults from a 96-Week Open-Label Study, I. van der Horst-Bruinsma, R. van B=
entum, F. D. Verbraak, T. Rath, J. Rosenbaum, M. Misterska-Sk=C3=B3ra, B. H=
oepken, O. Irvin-Sellers, B. VanLunen, L. Bauer, M. Rudwaleit
=E2=80=A2=C2=A0 Date/time: November 10, 2019: 4:30PM-6:00PM ET
=E2=80=A2=C2=A0 Location: GWCC Building B, B405-B407

CIMZIA Posters:

Certolizumab Pegol-Treated Patients with Non-Radiographic Axial Spondyloart=
hritis Demonstrate
Improvements in Sleep Quality and Other Patient Reported Outcomes, L. Gensl=
er, J. Kay, W. Maksymowych, N. Haroon, L. Bauer, B. Hoepken, N. de Peyrecav=
e, T. Kumke, A. Deodhar=C2=A0
=E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Certolizumab Pegol Improves Work and Household Productivity and Social Part=
icipation Over 1 Year of=C2=A0Treatment in Patients With Non-Radiographic A=
xial Spondyloarthritis, A. Deodhar, L. Gensler, J. Kay, W. Maksymowych, N. =
Haroon, R. Landew=C3=A9, M. Rudwaleit, S. Hall, L. Bauer, B. Hoepken, N. de=
Peyrecave, T. Kumke, D. van der Heijde=C2=A0
=E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Long=E2=80=91Term Certolizumab Pegol Treatment of Axial Spondyloarthritis i=
s Associated with Rapid and
Sustained Reduction of Active Inflammation and Minimal Structural Changes i=
n the Spine: 4=E2=80=91Year MRI Results, X. Baraliakos, S. Kruse, A. Auteri=
, N. de Peyrecave, T. Nurminen, T. Kumke, B. Hoepken, J. Braun, =C2=A0
=E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Achievement of Very Low Disease Activity and Remission Treatment Targets is=
Associated with Reduced Radiographic Progression in Patients with Psoriati=
c Arthritis Treated with Certolizumab Pegol, L. Coates, J. F. Merola, A. Ka=
vanaugh, P. Mease, O. Davies, O. Irvin-Sellers, T. Nurminen, D. van der Hei=
=E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Body Mass Index and Systemic Corticosteroid Use as Indicators of Disease Bu=
rden and Their Influence on the Safety Profile of Certolizumab Pegol Across=
Indications, A. Blauvelt, J. Curtis, C. Gaujoux-Viala, T. Kvien, W. Sandbo=
rn, K. Winthrop, C. Popova, X. Mariette
=E2=80=A2=C2=A0=C2=A0Date/time: November 12, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Bimekizumab Oral Presentations:

Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with =
Active Ankylosing Spondylitis: 48-Week Efficacy and Safety Results From a P=
hase 2b, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study, D. va=
n der Heijde, L. Gensler, A. Deodhar, X. Baraliakos, D. Poddubnyy, A. Kivit=
z, M. Oortgiesen, D. Baeten, N. Goldammer, J. Coarse, M. Farmer, M. Dougados
=E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 4:30PM-6:00PM ET
=E2=80=A2=C2=A0=C2=A0Location: GWCC Building B, B405-B407

Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with =
Active Psoriatic Arthritis: Disease Activity and Remission in a 48-week Pha=
se 2b, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study, P.=
Mease, L. Gossec, L. Coates, A. Gottlieb, D. Assudani, J. Coarse, O. Irvin=
-Sellers, D. Gladman
=E2=80=A2=C2=A0=C2=A0Date/time: November 13, 2019: 9:00AM =E2=80=93 10:30AM=
=E2=80=A2=C2=A0=C2=A0Location: GWCC Building B, B309
Dapirolizumab Pegol Oral Presentations:

Efficacy and Safety of Dapirolizumab Pegol in Patients with Moderately to S=
everely Active Systemic Lupus Erythematosus: A Randomized, Placebo-Controll=
ed Study, R. Furie, I. Bruce, T. D=C3=B6rner, M. Leon, P. Leszczy=C5=84ski,=
M. Urowitz, B. Haier, C. Brittain, J. Liu, C. Barbey, C. Stach=C2=A0
=E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 4:30PM-6:00PM ET
=E2=80=A2=C2=A0=C2=A0Location: GWCC Building A, A411-A412

UCB Sponsored Real-World Data on Chronic Rheumatic Diseases:

Gender Differences in Comorbidities and Treatment Utilization among Ankylos=
ing Spondylitis Patients Initiating a Biologic in a Real-World Setting, A. =
Sheahan, M. Balamane, E. Lee, R. Suruki
=E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Inadequate Response within a Year of Biologic and Oral Synthetic DMARD Trea=
tment Initiation among Psoriatic Arthritis Patients in the USA Real-World S=
etting, S. Grabich, A. Sheahan, O. Davies, R. Suruki=C2=A0
=E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

Opioid Use Surrounding Diagnosis of Inflammatory Arthritis, A. Sheahan, V. =
Sloan, J. Stark, R. Suruki
=E2=80=A2=C2=A0=C2=A0Date/time: November 12, 2019: 9:00AM-11:00AM ET
=E2=80=A2=C2=A0=C2=A0Location: Hall B5

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that p=
otently and selectively neutralizes IL-17A and IL-17F, two key cytokines dr=
iving inflammatory processes.^12=C2=A0IL-17A and IL-17F have similar pro-in=
flammatory functions and independently synergize with other inflammatory me=
diators to drive chronic inflammation and damage across multiple tissues.^1=

About Dapirolizumab Pegol
Dapirolizumab pegol is an investigational anti-CD40L pegylated Fab being de=
veloped in systemic lupus erythematosus (SLE) jointly by UCB and Biogen. Th=
rough interactions with its receptor, CD40, CD40L plays an important role i=
n regulating interactions between T cells and other immune cells, notably B=
cells and antigen presenting cells, and thus affects several important fun=
ctional events thought to be involved in autoimmune disease.

About CIMZIA^=C2=AE in the US=C2=A0
CIMZIA^=C2=AE is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Facto=
r). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizin=
g the pathophysiological effects of TNF-alpha.
CIMZIA is indicated for the treatment of adults with moderately to severely=
active rheumatoid arthritis (RA), adults with active psoriatic arthritis (=
PsA), and adults with active ankylosing spondylitis (AS). CIMZIA is indicat=
ed for the treatment of adults with active non-radiographic axial spondyloa=
rthritis (nr-axSpA) with objective signs of inflammation.

CIMZIA is also indicated for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy or phototherapy.=

In addition, it is indicated for reducing signs and symptoms of Crohn's dis=
ease (CD) and maintaining clinical response in adult patients with moderate=
ly to severely active disease who have had an inadequate response to conven=
tional therapy. See important safety information including risk of serious =
bacterial, viral and fungal infections and tuberculosis below.

Important Safety Information about CIMZIA^=C2=AE in the US=C2=A0

CIMZIA^=C2=AE is contraindicated in patients with a history of hypersensiti=
vity reaction to certolizumab pegol or to any of the excipients. Reactions =
have included angioedema, anaphylaxis, serum sickness, and urticaria.

Patients treated with CIMZIA are at increased risk for developing serious i=
nfections that may lead to hospitalization or death. Most patients who deve=
loped these infections were taking concomitant immunosuppressants such as m=
ethotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.
Reported infections include:

=C2=B7 Active tuberculosis (TB), including reactivation of latent TB. Patie=
nts with TB have frequently presented with disseminated or extrapulmonary d=
isease. Test patients for latent TB before CIMZIA use and during therapy. I=
nitiate treatment for latent TB prior to CIMZIA use.
=C2=B7 Invasive fungal infections, including histoplasmosis, coccidioidomyc=
osis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patien=
ts with histoplasmosis or other invasive fungal infections may present with=
disseminated, rather than localized, disease. Antigen and antibody testing=
for histoplasmosis may be negative in some patients with active infection.=
Consider empiric anti-fungal therapy in patients at risk for invasive fung=
al infections who develop severe systemic illness.
=C2=B7 Bacterial, viral, and other infections due to opportunistic pathogen=
s, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to=
initiating therapy in the following patients: with chronic or recurrent in=
fection; =C2=A0who have been exposed to TB; =C2=A0with a history of opportu=
nistic infection; who resided in or traveled in regions where mycoses are e=
ndemic; with underlying conditions that may predispose them to infection. M=
onitor patients closely for the development of signs and symptoms of infect=
ion during and after treatment with CIMZIA, including the possible developm=
ent of TB in patients who tested negative for latent TB infection prior to =
initiating therapy.

=C2=B7 Do not start CIMZIA during an active infection, including localized =
=C2=B7 Patients older than 65 years, patients with co-morbid conditions, an=
d/or patients taking concomitant immunosuppressants may be at greater risk =
of infection.
=C2=B7 If an infection develops, monitor carefully and initiate appropriate=

Lymphoma and other malignancies, some fatal, have been reported in children=
and adolescent patients treated with TNF blockers, of which CIMZIA is a me=
mber. CIMZIA is not indicated for use in pediatric patients.

=C2=B7 Consider the risks and benefits of CIMZIA treatment prior to initiat=
ing or continuing therapy in a patient with known malignancy.
=C2=B7 In clinical trials, more cases of malignancies were observed among C=
IMZIA-treated patients compared to control patients.
=C2=B7 In CIMZIA clinical trials, there was an approximately 2-fold higher =
rate of lymphoma than expected in the general U.S. population. Patients wit=
h rheumatoid arthritis, particularly those with highly active disease, are =
at a higher risk of lymphoma than the general population.
=C2=B7 Malignancies, some fatal, have been reported among children, adolesc=
ents, and young adults being treated with TNF blockers. =C2=A0Approximately=
half of the cases were lymphoma, while the rest were other types of malign=
ancies, including rare types associated with immunosuppression and malignan=
cies not usually seen in this patient population.
=C2=B7 Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare=
type of T-cell lymphoma, have been reported in patients treated with TNF b=
lockers, including CIMZIA. These cases have had a very aggressive disease c=
ourse and have been fatal. The majority of reported TNF blocker cases have =
occurred in patients with Crohn=E2=80=99s disease or ulcerative colitis, an=
d the majority were in adolescent and young adult males. =C2=A0Almost all o=
f these patients had received treatment with azathioprine or 6-mercaptopuri=
ne concomitantly with a TNF blocker at or prior to diagnosis. Carefully ass=
ess the risks and benefits of treating with CIMZIA in these patient types.
=C2=B7 Cases of acute and chronic leukemia were reported with TNF blocker u=


=C2=B7 Worsening and new onset congestive heart failure (CHF) has been repo=
rted with TNF blockers. Exercise caution and monitor carefully.


=C2=B7 Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness,=
and urticaria have been reported following CIMZIA administration. If a ser=
ious allergic reaction occurs, stop CIMZIA and institute appropriate therap=
y. =C2=A0The needle shield inside the removable cap of the CIMZIA prefilled=
syringe contains a derivative of natural rubber latex which may cause an a=
llergic reaction in individuals sensitive to latex.


=C2=B7 Use of TNF blockers, including CIMZIA, may increase the risk of reac=
tivation of hepatitis B virus (HBV) in patients who are chronic carriers. S=
ome cases have been fatal.
=C2=B7 Test patients for HBV infection before initiating treatment with CIM=
=C2=B7 Exercise caution in patients who are carriers of HBV and monitor the=
m before and during CIMZIA treatment.
=C2=B7 Discontinue CIMZIA and begin antiviral therapy in patients who devel=
op HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatm=


=C2=B7 TNF blockers, including CIMZIA, have been associated with rare cases=
of new onset or exacerbation of central nervous system and peripheral demy=
elinating diseases, including multiple sclerosis, seizure disorder, optic n=
euritis, peripheral neuropathy, and Guillain-Barr=C3=A9 syndrome.


=C2=B7 Rare reports of pancytopenia, including aplastic anemia, have been r=
eported with TNF blockers. Medically significant cytopenia has been infrequ=
ently reported with CIMZIA.
=C2=B7 Consider stopping CIMZIA if significant hematologic abnormalities oc=


=C2=B7 Do not use CIMZIA in combination with other biological DMARDS.=C2=A0


=C2=B7 Treatment with CIMZIA may result in the formation of autoantibodies =
and, rarely, in development of a lupus-like syndrome. Discontinue treatment=
if symptoms of a lupus-like syndrome develop.


=C2=B7 Patients on CIMZIA should not receive live or live-attenuated vaccin=


=C2=B7 The most common adverse reactions in CIMZIA clinical trials (=E2=89=
=A58%) were upper respiratory infections (18%), rash (9%), and urinary trac=
t infections (8%).=C2=A0

For full prescribing information, please visit=C2=A0

About CIMZIA^=C2=AE in the EU/EEA
In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate=
d for the treatment of moderate to severe active RA in adult patients inade=
quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu=
ding MTX.=C2=A0

CIMZIA can be given as monotherapy in case of intolerance to MTX or when co=
ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX=
is also indicated for the treatment of severe, active and progressive RA i=
n adults not previously treated with MTX or other DMARDs.

CIMZIA has been shown to reduce the rate of progression of joint damage as =
measured by X-ray and to improve physical function, when given in combinati=
on with MTX.

CIMZIA, in combination with MTX, is also indicated for the treatment of act=
ive psoriatic arthritis in adults when the response to previous DMARD thera=
py has been inadequate. CIMZIA can be given as monotherapy in case of intol=
erance to MTX or when continued treatment with MTX is inappropriate.

CIMZIA is also indicated in the EU for the treatment of adult patients with=
severe active axial spondyloarthritis (axSpA), comprising:=C2=A0

=C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w=
ho have had an inadequate response to, or are intolerant to non-steroidal a=
nti-inflammatory drugs (NSAIDs).=C2=A0
=C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS =
=E2=80=93 adults with severe active axSpA without radiographic evidence of =
AS but with objective signs of inflammation by elevated C-reactive protein =
(CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re=
sponse to, or are intolerant to NSAIDs.

CIMZIA is also indicated for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy.=C2=A0

About CIMZIA^=C2=AE in Fertility, Pregnancy and Lactation in the EU/EEA
Women of childbearing potential
The use of adequate contraception should be considered for women of childbe=
aring potential. For women planning pregnancy, continued contraception may =
be considered for 5 months after the last CIMZIA^=C2=AE dose due to its eli=
mination rate, but the need for treatment of the woman should also be taken=
into account (see below).
Data from more than 500 prospectively collected pregnancies exposed to CIMZ=
IA with known pregnancy outcomes, including more than 400 pregnancies expos=
ed during the first trimester, does not indicate a malformative effect of C=
IMZIA. However, the available clinical experience is too limited to, with a=
reasonable certainty, conclude that there is no increased risk associated =
with CIMZIA administration during pregnancy.
Animal studies using a rodent anti-rat TNF=CE=B1 did not reveal evidence of=
impaired fertility or harm to the foetus. However, these are insufficient =
with respect to human reproductive toxicity. Due to its inhibition of TNF=
=CE=B1, CIMZIA administered during pregnancy could affect normal immune res=
ponse in the newborn.
CIMZIA should only be used during pregnancy if clinically needed. Non-clini=
cal studies suggest low or negligible level of placental transfer of a homo=
logue Fab-fragment of certolizumab pegol (no Fc region).
In a clinical study 16 women were treated with certolizumab pegol (200 mg e=
very 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol =
plasma concentrations measured in 14 infants at birth were Below the Limit =
of Quantification (BLQ) in 13 samples; one was 0.042 =C2=B5g/ml with an inf=
ant/mother plasma ratio at birth of 0.09%. At Week 4 and Week 8, all infant=
concentrations were BLQ. The clinical significance of low levels certolizu=
mab pegol for infants is unknown. It is recommended to wait a minimum of 5 =
months following the mother's last CIMZIA administration during pregnancy b=
efore administration of live or live-attenuated vaccines (e.g. BCG vaccine)=
, unless the benefit of the vaccination clearly outweighs the theoretical r=
isk of administration of live or live-attenuated vaccines to the infants.
In a clinical study in 17 lactating women treated with CIMZIA, minimal tran=
sfer of certolizumab pegol from plasma to breast milk was observed. The per=
centage of the maternal certolizumab pegol dose reaching an infant during a=
24 hour period was estimated to 0.04% to 0.30%. In addition, since certoli=
zumab pegol is a protein that is degraded in the gastrointestinal tract aft=
er oral administration, the absolute bioavailability is expected to be very=
low in a breastfed infant. Consequently, CIMZIA can be used during breastf=

Important Safety Information about CIMZIA^=C2=AE in the EU/EEA=C2=A0
CIMZIA^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) =
in controlled and open label trials for up to 92 months. The commonly repor=
ted adverse reactions (1-10%) in clinical trials with CIMZIA and post-marke=
ting were viral infections (includes herpeszoster, papillomavirus, influenz=
a), bacterial infections (including abscess), rash, headache (including mig=
raine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosi=
nophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypert=
ension, pruritus (any sites), hepatitis (including hepatic enzyme increase)=
, injection site reactions, and nausea. Serious adverse reactions include s=
epsis, opportunistic infections, tuberculosis (including miliary, dissemina=
ted and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid organ tu=
mours, angioneurotic oedema, cardiomyopathies (includes heart failure), isc=
hemic coronary artery disorders, pancytopaenia, hypercoagulation (including=
thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculiti=
s, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephrop=
athy (includes nephritis). In RA controlled clinical trials, 4.4% of patien=
ts discontinued taking CIMZIA due to adverse events vs. 2.7% for placebo.

CIMZIA is contraindicated in patients with hypersensitivity to the active s=
ubstance or any of the excipients, active tuberculosis or other severe infe=
ctions such as sepsis or opportunistic infections and moderate to severe he=
art failure.

Serious infections including sepsis, tuberculosis and opportunistic infecti=
ons (e.g., histoplasmosis, nocardia, candidiasis) have been reported in pat=
ients receiving CIMZIA. Some of these events have been fatal. Monitor patie=
nts closely for signs and symptoms of infections including tuberculosis bef=
ore, during and after treatment with CIMZIA. Treatment with CIMZIA must not=
be initiated in patients with a clinically important active infection. If =
an infection develops, monitor carefully and stop CIMZIA until the infectio=
n is controlled. Before initiation of therapy with CIMZIA, all patients mus=
t be evaluated for both active and inactive (latent) tuberculosis infection=
. If active tuberculosis is diagnosed prior to or during treatment, CIMZIA =
therapy must not be initiated and must be discontinued. If latent tuberculo=
sis is diagnosed, appropriate anti-tuberculosis therapy must be started bef=
ore initiating treatment with CIMZIA. Patients should be instructed to seek=
medical advice if signs/symptoms (e.g., persistent cough, wasting/weight l=
oss, low grade fever, listlessness) suggestive of tuberculosis occur during=
or after therapy with CIMZIA.=C2=A0

Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including CIMZIA who are chronic carriers of the virus (i.e., surface =
antigen positive). Some cases have had a fatal outcome. Patients should be =
tested for HBV infection before initiating treatment with CIMZIA. Carriers =
of HBV who require treatment with CIMZIA should be closely monitored and in=
the case of HBV reactivation CIMZIA should be stopped and effective anti-v=
iral therapy with appropriate supportive treatment should be initiated.=C2=

TNF antagonists including CIMZIA may increase the risk of new onset or exac=
erbation of clinical symptoms and/or radiographic evidence of demyelinating=
disease, including multiple sclerosis; of formation of autoantibodies and =
uncommonly of the development of a lupus-like syndrome; of severe hypersens=
itivity reactions. If a patient develops any of these adverse reactions, CI=
MZIA should be discontinued and appropriate therapy instituted.=C2=A0

With the current knowledge, a possible risk for the development of lymphoma=
s, leukaemia or other malignancies in patients treated with a TNF antagonis=
t cannot be excluded. Rare cases of neurological disorders, including seizu=
re disorder, neuritis and peripheral neuropathy, have been reported in pati=
ents treated with CIMZIA.=C2=A0

Adverse reactions of the haematologic system, including medically significa=
nt cytopaenia, have been reported with CIMZIA. Advise all patients to seek =
immediate medical attention if they develop signs and symptoms suggestive o=
f blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding=
, pallor) while on CIMZIA. Consider discontinuation of CIMZIA therapy in pa=
tients with confirmed significant haematological abnormalities.=C2=A0

The use of CIMZIA in combination with anakinra or abatacept is not recommen=
ded due to a potential increased risk of serious infections. As no data are=
available, CIMZIA should not be administered concurrently with live vaccin=
es. The 14-day half-life of CIMZIA should be taken into consideration if a =
surgical procedure is planned. A patient who requires surgery while on CIMZ=
IA should be closely monitored for infections.=C2=A0

CIMZIA was studied in 325 patients with active axial spondyloarthritis (axS=
pA) and in 409 patients with psoriatic arthritis (PsA) for up to four years=
. The safety profile for axSpA and PsA patients treated with CIMZIA was con=
sistent with the safety profile in RA and previous experience with CIMZIA.=

CIMZIA was studied in 1112 patients with psoriasis in controlled and open-l=
abel studies for up to 18 months. The safety profile of CIMZIA 400 mg every=
two weeks and CIMZIA 200 mg every two weeks were generally similar.=C2=A0

Please consult the full prescribing information in relation to other side e=
ffects, full safety and prescribing information. European SmPC date of revi=
sion June 2019. https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-=

CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies.

For further information, UCB:=C2=A0

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Brand Communications
Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.christopher@ucb.com=C2=A0

About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases in immunol=
ogy and neurology. With 7,500 people in approximately 40 countries, the com=
pany generated revenue of =E2=82=AC 4.6 billion in 2018. UCB is listed on E=
uronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements =E2=80=93 UCB
This press release contains forward-looking statements based on current pla=
ns, estimates and beliefs of management. All statements, other than stateme=
nts of historical fact, are statements that could be deemed forward-looking=
statements, including estimates of revenues, operating margins, capital ex=
penditures, cash, other financial information, expected legal, political, r=
egulatory or clinical results and other such estimates and results. By thei=
r nature, such forward-looking statements are not guarantees of future perf=
ormance and are subject to risks, uncertainties and assumptions which could=
cause actual results to differ materially from those that may be implied b=
y such forward-looking statements contained in this press release. Importan=
t factors that could result in such differences include: changes in general=
economic, business and competitive conditions, the inability to obtain nec=
essary regulatory approvals or to obtain them on acceptable terms, costs as=
sociated with research and development, changes in the prospects for produc=
ts in the pipeline or under development by UCB, effects of future judicial =
decisions or governmental investigations, product liability claims, challen=
ges to patent protection for products or product candidates, changes in law=
s or regulations, exchange rate fluctuations, changes or uncertainties in t=
ax laws or the administration of such laws and hiring and retention of its =
employees. UCB is providing this information as of the date of this press r=
elease and expressly disclaims any duty to update any information contained=
in this press release, either to confirm the actual results or to report a=
change in its expectations.

There is no guarantee that new product candidates in the pipeline will prog=
ress to product approval or that new indications for existing products will=
be developed and approved. Products or potential products which are the su=
bject of partnerships, joint ventures or licensing collaborations may be su=
bject to differences between the partners. Also, UCB or others could discov=
er safety, side effects or manufacturing problems with its products after t=
hey are marketed. Moreover, sales may be impacted by international and dome=
stic trends toward managed care and health care cost containment and the re=
imbursement policies imposed by third-party payers as well as legislation a=
ffecting biopharmaceutical pricing and reimbursement.


1. Kay J, et al. Earlier Treatment of Non-Radiographic Axial Spondyloarthri=
tis with Certolizumab Pegol Results in Improved=C2=A0Clinical and Patient-R=
eported Outcomes. Abstract to be presented at ACR/ARHP 2019, November 8-13 =
Atlanta, Georgia.=C2=A0
2. Khmelinskii N, et al. The Role of Imaging in Diagnosing Axial Spondyloar=
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Patients with Axial Spondyloarthritis Following 1 Year of Treatment with C=
ertolizumab Pegol: 48-Week Interim Results from a 96-Week Open-Label Study.=
Abstract to be presented at ACR/ARHP 2019, November 8-13 Atlanta, Georgia.=
5. Gensler L, et al. Certolizumab Pegol-Treated Patients with Non-Radiograp=
hic Axial Spondyloarthritis Demonstrate=C2=A0Improvements in Sleep Quality =
and Other Patient Reported Outcomes. Abstract to be presented at ACR/ARHP 2=
019, November 8-13 Atlanta, Georgia.=C2=A0
6. Deodhar A, et al. Certolizumab Pegol Improves Work and Household Product=
ivity and Social Participation Over 1 Year of=C2=A0Treatment in Patients Wi=
th Non-Radiographic Axial Spondyloarthritis. Abstract to be presented at AC=
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7. Baraliakos X, et al. Long-Term Certolizumab Pegol Treatment of Axial Spo=
ndyloarthritis is Associated with Rapid and Sustained Reduction of Active I=
nflammation and Minimal Structural Changes in the Spine: 4=E2=80=91Year MRI=
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8. Merola J, et al. Achievement of Very Low Disease Activity and Remission =
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ith Moderately to Severely Active Systemic Lupus Erythematosus: A Randomize=
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